Cook

Basic Information

• Brand Name: Cook
• Primary DI: 00827002143371
• Version / Model: G14337
• Catalog Number: 028006
• Company Name: COOK INCORPORATED
• Labeler DUNS: 042823948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2020-09-22
• Public Version Status: Update
• Public Device Record Key: 3b9348b3-3927-4902-b56e-54f4f56196fe

Device Description

UPJ Occlusion Balloon Catheter Set

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EYB	CATHETER, URETERAL, GASTRO-UROLOGY	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46843	Ureteropelvic balloon catheter	A flexible tubular device with an inflatable balloon at the distal end that is placed via the ureter up to the ureteropelvic junction (UPJ) to primarily provide temporary occlusion of the UPJ to prevent stone fragments from lodging in the ureter during a lithotripsy procedure. It may also be used for the injection of a contrast medium for fluoroscopic visualization of UPJ structures, and some types may facilitate the introduction of a compatible endoscope. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002143371	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place.